4.2 Ethics

The international ethical guidelines for biomedical research involving human subjects (see Annex VI) should be implemented in each clinical trial. An ethics committee, according to each institution's guidelines should review each trial.

Whenever applicable, rescue treatment may be provided to patients involved in a clinical trial involving the use of a placebo or unproven treatment. Use of the rescue treatment may be a secondary outcome measure.

In some countries and hospitals, there are ethical issues that restrict the use of clinical trials. In some cases, the use of a placebo is even illegal, particularly for patients suffering from certain illnesses, such as cancer. Therefore, clinical trials must always be conducted within the framework of the prevailing law in a given country or state.